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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmApril 12, 2004
Date PostedSeptember 23, 2004
Recall Status1 Terminated 3 on May 10, 2005
Recall NumberZ-1484-04
Recall Event ID 29960
Product Classification Heart-Valve, Allograft - Product Code MIE
ProductCryoValve, Conduit and Pulmonary Valve and Conduit
Code Information Donor #66949, Serial #7988716, Model #SGPV00
Recalling Firm/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
For Additional Information ContactMr. P. Tyler Cochran
770-419-3355
Manufacturer Reason
for Recall		CryoLife received information regarding a positive culture for Group A Streptococcus infection in a recipient of tissue procured from the attached donor.
FDA Determined
Cause 2		Other
ActionConsignee was notified via telephone on 4/12/2004. The tissue was returned and destroyed.
Quantity in Commerce1 tissue
DistributionNM
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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